A large majority of the population will experience back pain at some point in their lives that results from a spinal condition. The pain may range from general discomfort to disabling pain that immobilizes the individual. One type of adverse spinal condition is spinal stenosis which occurs when the spinal canal or nerve root canals become too narrow and reduces the space for the passage of blood vessels and nerves resulting in low back pain as well as pain in the legs. Spinal stenosis can result from the natural aging process, or may be a result of a degenerative disease or condition.
One method currently used for treating spinal stenosis is a decompressive laminectomy. This procedure requires that the patient be given a general anesthesia as an incision is made in the patient to access the point of injury and repair the damage. This procedure may result in blood loss, an increased chance of significant complications, and usually results in an extended hospital stay of two or more nights. This procedure is further complicated when the patient is elderly, which is often the case when treating spinal injuries of this type.
Medical treatments that can be performed in a minimally invasive manner are greatly sought after by the medical community and patients alike. The term xe2x80x9cminimally invasivexe2x80x9d herein shall be understood as being accomplished without the need to resect tissue in order to gain access to the application point. Minimally invasive techniques are advantageous because they can be performed with the use of a local anesthesia, have a shorter recovery period, result in little to no blood loss, and greatly decrease the chances of significant complications. Minimally invasive techniques additionally are usually less expensive for the patient.
The present invention is a system and method of positioning a spacer within a patient. The spacer has a first form having a reduced size such that it can be inserted into the patient in a minimally invasive manner. Once inserted to an application point within the patient, the spacer is expanded to a desired size. In one embodiment, a conduit is placed within the patient to a predetermined position between adjacent spinous processes. The spacer is inserted in a first form through the conduit to the application point and then changed to the second form having an expanded size to maintain the adjacent spinous processes in a predetermined alignment.
In one embodiment, the spacer is constructed of a flexible material that is sized to fit within the opening in the patient and be delivered to the application point. Biomaterial is then fed into the spacer to expand the size to the desired dimensions. In another embodiment, the spacer is constructed of a material that is sized to fit within the opening in the patient and be delivered to the application point. Once at this point, the spacer expands to the desired size and dimensions.
In one embodiment, a conduit is inserted within the patient for delivering the spacer to the application point. The conduit is hollow to provide a pathway for delivering the spacer. In the embodiment using a biomaterial to expand the spacer, the hollow conduit may also provide a means for delivering the biomaterial to the interior of the spacer.
In one embodiment, the conduit is comprised of one or more conduit sections of increasing size. A first conduit section is placed within the patient to form a small opening, and then increasingly larger conduit sections are inserted within the opening until the opening is the desired size. Any number of different conduit sections may be used in this process. In one embodiment, each of the conduit sections has a length such that a first end can be positioned at the application point, and the second end remains outside of the patient where it can be handled by medical personal.